RAN-TADALAFIL TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
19-07-2017
Vissa dokument för denna produkt är för närvarande inte tillgängliga, du kan skicka en begäran till vår kundservice och vi kommer att meddela dig så snart vi kan få dem.
Skicka förfrågan.
Skicka förfrågan.
Aktiva substanser:
TADALAFIL
Tillgänglig från:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC-kod:
G04BE08
INN (International namn):
TADALAFIL
Dos:
2.5MG
Läkemedelsform:
TABLET
Sammansättning:
TADALAFIL 2.5MG
Administreringssätt:
ORAL
Enheter i paketet:
4/28/30/56/100/500
Receptbelagda typ:
Prescription
Terapiområde:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0149485003; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2016-07-12
Produktens egenskaper
Page 1 of 48
PRODUCT MONOGRAPH
PR
RAN™-TADALAFIL
(tadalafil tablets, USP)
2.5 mg, 5 mg tablets (for _Once-a-Day_ use)
10 mg, 20 mg tablets (for _“On-Demand”_ dosing)
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
TREATMENT OF ERECTILE DYSFUNCTION (ED)
Ranbaxy Pharmaceuticals Canada Inc.
DATE OF REVISION:
126 East Drive
July 17, 2017
Brampton, Ontario
L6T 1C1
Control# 207323
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
Page 2 of 48
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
3
SUMMARY PRODUCT INFORMATION
..............................................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................................
3
CONTRAINDICATIONS
.........................................................................................................................
3
WARNINGS AND PRECAUTIONS
.......................................................................................................
4
ADVERSE REACTIONS
.........................................................................................................................
8
DRUG
INTERACTIONS........................................................................................................................
11
DOSAGE AND ADMINISTRATION
...................................................................................................
14
OVERDOSAGE
......................................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
16
STORAGE AND STABILITY
...............................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 21
PAR
Läs hela dokumentet
